Implantable medical device providing adaptive neurostimulation therapy for incontinence

ABSTRACT

In general, the disclosure is directed to an implantable neurostimulator and system capable of providing adaptive neurostimulation therapy to alleviate incontinence. The neurostimulator operates according to a set of stimulation parameters stored in memory. During operation, information is obtained from the patient, the implanted neurostimulator, one or more implanted sensors, or some combination thereof. A processor analyzes the information to automatically generate proposed adjustments to the stimulation parameters applied by the neurostimulator. The adjustments provide an adaptive neurostimulation therapy that supports or enhances therapeutic efficacy based on the information.

PRIORITY

This applications claims priority from U.S. Provisional Application No.60/655,561 filed on Feb. 23, 2005 entitled “IMPLANTALBE MEDICAL DEVICEPROVIDING ADAPTIVE NEUROSTIMULATION THERAPY FOR INCONTINENCE”, thedisclosure of which is incorporated in its entirety by reference herein.

TECHNICAL FIELD

The invention relates to implantable medical devices and, moreparticularly, devices for delivering neurostimulation therapy forincontinence.

BACKGROUND

Many people suffer from involuntary urine leakage, i.e., urinaryincontinence. Others may suffer from blocked or restricted urine flow.Other urinary disorders include frequent urination, sudden urges tourinate, problems starting a urine stream, painful urination, problemsemptying the bladder completely, and recurrent urinary tract infections.A physician uses an urodynamic test to study how a patient stores andreleases urine. During the test, the physician obtains urodynamicinformation based on one or more physiological conditions within theurinary tract.

Different muscles, nerves, organs and conduits within the urinary tractcooperate to collect, store and release urine. A variety of disordersmay compromise the urinary tract performance and contribute toincontinence or restricted flow. Many of the disorders may be associatedwith aging, injury or illness. For example, aging can often result inweakened sphincter muscles, which cause incontinence, or weakenedbladder muscles, which prevent complete emptying. Some patients also maysuffer from nerve disorders that prevent proper triggering and operationof the bladder or sphincter muscles.

Neurostimulation therapy is applied to alleviate symptoms associatedwith a variety of pelvic floor disorders including urinary incontinence.An implantable neurostimulator applies electrical stimulation pulses tosacral or pudendal nerves to provide bladder control. Theneurostimulator may include a stimulation pulse generator and one ormore leads carrying electrodes for delivery of the stimulation pulses tonerve tissue. An external monitor/programmer communicates with theimplanted neurostimulator by wireless telemetry to set stimulationparameters such as frequency, pulse width, amplitude and duration, andstart and stop stimulation to permit voluntary voiding.

Stimulation parameters are typically loaded into the neurostimulator orexternal monitor/programmer at a clinic. The parameters may be organizedas one or more distinct programs that can be selected using the externalmonitor/programmer. Also, the external monitor/programmer may permit apatient to adjust one or more individual parameters. The parameters maybe reprogrammed in a subsequent clinical visit if the results providedby existing parameters are unsatisfactory.

Existing systems such as these could benefit from more frequent, and/ormore logical changes to the stimulation parameters based on individualpatients.

SUMMARY

In general, the invention is directed to an implantable neurostimulatorand system capable of providing adaptive neurostimulation therapy toalleviate fecal or urinary incontinence. The neurostimulator operatesaccording to a set of stimulation parameters stored in memory. Duringoperation, information is obtained from the patient, the implantedneurostimulator, one or more implanted sensors, or some combinationthereof. A processor analyzes the information to automatically generateproposed adjustments to the stimulation parameters applied by theneurostimulator. The processor's analysis is based on generally onadaptive logic. The adjustments provide an adaptive neurostimulationtherapy that supports or enhances therapeutic efficacy based on theinformation obtained.

The information obtained during the method may indicate a level ofefficacy achieved by the neurostimulation therapy. For example, theinformation may include voiding event information that identifiesvoiding attempts, involuntary leakage episodes, episodes of discomfort(e.g. bladder discomfort), or other incontinence symptoms orcharacteristics. In addition, the information may include physiologicalconditions such as pressure, flow, and contractile force. Alternatively,the information may indicate a physiological state of the patient, suchas an activity type (e.g., working, driving, sleeping), activity level(e.g., strenuous, moderate, or resting), or posture (standing, sitting,lying down).

The processor applies a set of adaptation logic to the gatheredinformation to formulate proposed adjustments to the stimulationparameters. The processor can automatically program the implantedneurostimulator to apply the adjusted stimulation parameters, or providethe patient with the option of selecting the new stimulation parameters.Alternatively, the processor may present the proposed adjustedstimulation parameters to a healthcare provider for approval prior toprogramming the neurostimulator. The external monitor/programmer caninclude the processor that performs the analysis and associatedadjustments. In other embodiments, the external monitor/programmertransmits the information to a processor in a remote location, a remoteprogrammer, which analyzes the information and generates theadjustments. Alternatively, the processor can be included in theimplantable neurostimulator or sensor(s) if utilized.

In one embodiment, the invention provides a method comprising receiving,in an external programmer, information relating to efficacy ofneurostimulation therapy delivered by an implanted neurostimulator tomanage urinary or fecal incontinence, adjusting, in a processor one ormore stimulation parameters of the neurostimulation therapy based on thereceived information, and inputting the adjusted parameters from theprocessor to the implanted neurostimulator.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram illustrating a neurostimulation systemproviding adaptive neurostimulation therapy for incontinence.

FIG. 2 is a block diagram illustrating an implantable sensor.

FIG. 3 is a block diagram illustrating an external monitor/programmer.

FIG. 4 is a block diagram illustrating an implantable neurostimulator.

FIG. 5 is a block diagram of a remote monitor/programmer system.

FIG. 6 is block diagram illustrating a system for remote monitoring andprogramming of implantable neurostimulators.

FIG. 7 is flow diagram illustrating operation of an externalmonitor/programmer to modify neurostimulation parameters based oninformation obtained from a neurostimulator, an implantable sensor, anda patient.

FIG. 8 is flow diagram illustrating operation of a remote programmer tomodify neurostimulation parameters based on information obtained from aneurostimulator, an implantable sensor, and a patient.

DETAILED DESCRIPTION

Embodiments of the invention can be utilized to provide therapy and/oraffect pelvic floor disorders. Examples of pelvic floor disorders thatcan be treated using a device and/or method of the invention include,but are not limited to, urinary control disorders, and fecal controldisorders. In one embodiment of the invention, urinary incontinence,fecal incontinence, or some combination thereof are treated usingdevices and/or methods of the invention.

Embodiments of the invention provide therapy for the various pelvicfloor disorders through stimulation of one more nerves of the pelvicfloor. Examples of these nerves include, but are not limited to, thesacral nerves, and the pudendal nerves. In one embodiment, the sacralnerves are simulated, in another, the pudendal nerves are stimulated,and in yet another embodiment, both the sacral and pudendal nerves arestimulated.

FIG. 1 is a schematic diagram illustrating a neurostimulation system 10providing adaptive neurostimulation therapy for incontinence. As shownin FIG. 1, system 10 includes an implantable neurostimulator 12.Neurostimulator 12 is implanted within patient 14 to deliverneurostimulation therapy for control of the function of bladder 16.Neurostimulator 12 may include at least one lead 17 carrying one or moreelectrodes for delivery of neurostimulation pulses to sacral nerveswithin the pelvic floor of patient 14. One embodiment includes animplanted urodynamic sensor 20 within bladder 16 to sense physiologicalconditions such as flow, pressure, contractile force and the like.Sensor 20 may be implanted within bladder 16, urethra 18 or elsewherewithin the body of patient 14. Also, in some embodiments, multiplesensors 20 may be implanted within patient 14.

In embodiments that include sensor 20, neurostimulator 12 may receiveinformation from sensor 20 via wireless telemetry. In addition, anexternal monitor/programmer 22 may receive information fromneurostimulator 12 and/or sensor 20 by wireless telemetry. Inalternative embodiments, sensor 20 may be integrated within the housingof neurostimulator 12 or coupled to the neurostimulator 12 via one ormore leads. External monitor/programmer 22 also may transmit informationto neurostimulator 12, such as adjustments to stimulation parameters tobe applied by the neurostimulator 12. The adjustments may be made basedon the information received from neurostimulator 12, sensor 20, patient14, or some combination thereof. For example, externalmonitor/programmer 22 may take the form of a patient programmer thatreceives information from patient 14 as user input provided via a userinterface.

External monitor/programmer 22 may record the received information,analyze the information, and adjust stimulation parameters based on theinformation or some combination thereof. Alternatively, externalmonitor/programmer 22 may record information and transmit theinformation to a remote monitoring/programming system 26 via a network24. In this case, remote monitoring/programming system 26 analyzes theinformation to generate adjustments to stimulation parameters, andtransmits the adjustments to external monitor/programmer 22 forapplication to neurostimulator 12. One of skill in the art will alsounderstand and appreciate that a processor responsible for analyzing thereceived information and proposing or instituting adjusted stimulationparameters could also be associated with the neurostimulator 12. As usedherein, associated with refers to a structure that is either housed withor within a device, or attached to a device via a lead. In this case,the information from external monitor/programmer 22 and sensor 20, ifapplicable, would be transmitted to the processor associated withneurostimulator 12 via wireless telemetry.

One or more clinician terminals 28 may be coupled to network 24 toreceive or access notifications of stimulation parameter adjustmentsgenerated by external monitor/programmer 22 or remotemonitoring/programming system 26. In one embodiment, a clinicianterminal 28 can be used by a clinician to reject or approve stimulationparameter adjustments. In the case of approval, externalmonitor/programmer 22 proceeds to make the adjustments to thestimulation parameters by downloading or inputting the adjustments toimplanted neurostimulator 12, e.g., as a new stimulation program, newparameters, or parameter adjustments. Alternatively, the clinician mayrequire a clinical visit by patient 14 so that the clinician maysupervise the parameter adjustments using a physician programmer.

Network 24 may take the form of a local area network, wide area networkor global network such as the Internet. Remote monitoring/programmingsystem 26 may include a web server to generate web pages containingproposed parameter adjustments for viewing via clinician terminal. Inaddition, remote monitoring/programming system 26 may include an emailserver for delivery of email notifications of proposed parameteradjustments. Clinician terminal 28 may be any client device coupled tonetwork 24, such as a personal computer, personal digital assistant,interactive television, mobile telephone, or the like. Using clinicianterminal 28, a clinician accesses web pages generated by remotemonitoring/programming system 26 and receives email notificationsadvising the clinician of new information or proposed parameteradjustments for patient 14.

If external monitor/programmer 22 handles analysis of information andgeneration of proposed parameter adjustments, the adjustments andinformation still may be transmitted to remote monitoring/programmingsystem 26 so that a clinician may review the information and adjustmentsvia clinician terminal 28. In this case, external monitor/programmer 22provides the intelligence for analysis and adjustment, but remotemonitoring/programming system 26 supports reporting and approval, ifnecessary, prior to implementation of the adjustments. In otherembodiments, remote monitoring/programming system 26 provides theintelligence for analysis and adjustment, as well as the reporting andapproval mechanism. In this case, external monitor/programmer 22 servesas a conduit for collection and transmission of patient information andprogramming of implanted neurostimulator 12 to implement stimulationparameter adjustments. In some embodiments, clinician approval will onlybe necessary for certain stimulation parameter adjustments for exampleadjustments of a greater magnitude than a pre-determined limit.

In some embodiments, stimulation parameter adjustments may be madeautomatically by external monitor/programmer 22, either independently orat the direction of remote monitoring/programming system 26. In manycircumstances, however, it will be desirable to obtain clinicianapproval prior to downloading or inputting stimulation parameteradjustments into neurostimulator 12. For this reason, it is desirablethat remote monitoring/programming system 26 supports the generation ofnotifications and web pages containing detailed reports so that theclinician has the information necessary to make a decision concerningstimulation parameter adjustment. Remote monitoring/programming system26 may manage information and parameter adjustment decisions formultiple patients 14 as well as multiple clinicians. In each case,external monitor/programmer 22 and remote monitoring/programming system26 cooperate to provide adaptive adjustment of stimulation parametersapplied by neurostimulator 12 for management of incontinence.

The information obtained by external monitor/programmer 22 may beprovided by neurostimulator 12, sensor 20, patient 14, or somecombination thereof. In the case of neurostimulator 12, the informationmay include operational information relating to the stimulation therapydelivered by the neurostimulator 12. Examples of operational informationinclude battery status, charging status, lead impedance, parameter setsapplied by neurostimulator 12, telemetry status, time since implant ofthe neurostimulator 12, and information regarding the elapsed time sincethe stimulation parameters were adjusted. In some embodiments, theparameter sets can include details regarding the frequency, amplitude,and pulse width of stimulation, cycling parameters, identification ofthe electrodes being used, and other similar parameters. Also, in someembodiments, implanted neurostimulator 12 may serve to receiveinformation from sensor 20 and forward the information to externalmonitor/programmer 22. Alternatively, in other embodiments, sensor 20may transmit information directly to external monitor/programmer 22.

Sensor 20, or multiple sensors, may provide a variety of informationindicative of the level of efficacy achieved by the neurostimulationtherapy delivered by neurostimulator 12. The information may be anyinformation relating to the function of the bladder 16, or any othersegment of the patient's urinary tract, in storing releasing and passingurine. For example, sensor 20 may monitor parameters such as bladderpressure, bladder contractile force, urinary sphincter pressure, urineflow rate, urine flow pressure, voiding amount, and the like.

Other examples of sensed information include urine flow velocity, urineor bladder temperature, impedance, urinary pH, or chemical constituencyof the urine. Any of such information may reveal the effect of theneurostimulation therapy on the physiological function of bladder 16,urethra 18 or the urinary sphincter. For example, if sensor 20 indicatesexcessive pressure, excessive contractile force, or involuntary urineflow (i.e., leakage) in response to a set of stimulation parameters, itmay be desirable to dynamically adjust the stimulation parameters toreduce the pressure or contractile force, and thereby enhance efficacy.

In still other embodiments, one or more sensors 20 may be implantedwithin patient 14 to sense a physiological state of the patient. Forexample, a sensor may be deployed to sense cardiac activity, respiratoryactivity, electromyographic activity, or the like, as an indication ofpatient activity level. Such activity level information, in conjunctionwith other information, may be useful in determining adjustments tostimulation parameters. Other types of sensors 20 also may detect aposture or activity level of the patient. For example, an accelerometermay detect an elevated activity level, e.g., during exercise, whileother sensors may detect whether the patient is sitting, standing orlying down. In addition, some of the information obtained by suchsensors, such as respiration activity, may be analyzed to determine,e.g., whether the patient is sleeping.

Information obtained from patient 14 includes information entered intoexternal monitor/programmer 22 via a user interface such as a set ofbuttons, a keypad, a touchscreen, or other input media. Like theinformation obtained from sensor 20, the information obtained frompatient 14 also may indicate a level of efficacy achieved by theneurostimulation therapy. For example, the information may includeinformation regarding voiding, such as for example voiding eventinformation that identifies urine voiding attempts, involuntary leakageepisodes, timing of voiding, flow, or other urinary incontinencesymptoms and characteristics. Voiding event information, such as theoccurrence or frequency of leakage, may be very helpful in evaluatingthe efficacy of existing stimulation parameters, and devising parameteradjustments to enhance efficacy. In embodiments of the invention fortreating fecal incontinence, for example, the information may includefecal voiding attempts, involuntary fecal voiding, timing of fecalvoiding, characteristics of the fecal bolus, or other fecal incontinencecharacteristics and symptoms.

Other information obtained from patient 14 may indicate a physiologicalstate of the patient, such as an activity type (e.g., working, driving,sleeping), activity level (e.g., strenuous, moderate, or resting), orposture (standing, sitting, lying down). Input such as this can berelevant because the efficacy of particular stimulation parameters mayvary as the physiological state of the patient changes. For example, aset of stimulation parameters may be more effective when a patient islying down than when the patient is sitting. When the patient sits down,for example, additional pressure may be exerted on the bladder. In thiscase, a dynamic increase in stimulation amplitude or frequency may bedesirable to prevent involuntary leakage.

Information regarding urine flow may include for example, strength offlow, stability of flow, ease of instituting flow, and amount of flow.As evidenced by this non-exhaustive list, a number of the relevant typesof information are subjective and could be rated by the patient using arelative scale. Urine flow could be input by the user after measuringthe voided amount. In embodiments of the invention that utilizesensor(s), voiding volume could be determined by the sensor(s), whichcould obviate the need for the patient to measure and enter the voidingvolume.

Information regarding the comfort of the patient 14 may also beobtained. For example, bladder discomfort can be noted, and rated on arelative scale by the user. IN yet another embodiment, the patient caninput information regarding the overall subjective feeling of thepatient 14 with respect to the neurostimulation therapy. This inputcould again be based on rating the overall feeling on a relative scale.

Also, in some embodiments, a patient 14 may be permitted to enterpatient preferences, e.g., based on subjective sensations experience bythe patient. For example, a patient 14 may enter information indicatingthat a stimulation level, e.g., amplitude, pulse width or pulse rate, isunpleasant or even painful. In addition, the patient 14 may enterinformation for stimulation levels that seems to have no perceivedefficacy from the patient's perspective. In some embodiments, a patient14 may also be permitted to enter an overall subjective indication ofhow they are feeling, or how they perceive the stimulation to beaffecting their urological concern, i.e. an indication of overallquality of life with regard to the stimulation therapy.

All of the information obtained by external monitor/programmer 22 orneurostimulator 12 may be temporally correlated so that it is possibleto evaluate the conditions experienced by a patient, e.g., at the timeof a significant voiding event. For example, if the patient experiencesleakage, it may be useful to evaluate the stimulation parameters thatwere applied at the time of leakage, the activity level of the patientat the time of leakage, the physiological conditions sensed by sensor 20at the time of leakage, and any recently input subjective indications bypatient 14. In this manner, it is possible to ascertain whether astimulation parameter adjustment should be a global adjustment, orpossibly a specific adjustment to a program applied at the time ofleakage, such as a stimulation program formulated for periods of rest orexercise.

In response to the information obtained from patient 14, sensor 20,neurostimulator 12, or some combination thereof, the processor applies aset of adaptation logic to the gathered information to formulateproposed adjustments to the stimulation parameters to be applied byneurostimulator 12. As already indicated, the processor functions may beassociated with the external monitor/programmer 22, remotemonitoring/programming system 26, the neurostimulator 12, the sensor 20,or some combination thereof. The adaptation logic may take the form of afunction or set of functions, expressed mathematically or in a lookuptable, that weight various informational items with predeterminedcoefficients and sum the weighted items to produce a parameteradjustment. In one embodiment, the adaptation logic could be based atleast in part on some combination of physician- and/ormanufacturer-determined safety ranges, efficacy of the stimulation, andbattery life. In another embodiment, the adaptation logic includesweighting of all of the information received by the externalmonitor/programmer 22, the implantable neurostimulator 12, and thesensor 20 if applicable. In a further embodiment, the adaptation logiccould also include weighting of other parameters input via a clinician,either through initial programming of the processor, or via a remotemonitoring/programming system 26. In one embodiment, the safety ranges,whether clinician-determined, or manufacturer-determined, set theabsolute limits of the parameter adjustment and/or are weighted mostheavily by the adaptation logic.

The stimulation parameter adjustments may be expressed as an upward ordownward change in one or more parameters such as amplitude, pulse widthor frequency. The stimulation parameter adjustments may be expressed asan absolute magnitude of adjustment, or an incremental adjustment. Inother words, the stimulation parameter adjustments may be applied in asingle step in the amount specified by the output of the processor. Ifthe adaptation logic, upon analysis of the information, specifies anincrease of 20 Hz in the frequency of the stimulation pulses applied byneurostimulator 12, that 20 Hz increase is proposed as an instantadjustment to the stimulation parameters. In some cases, an absoluteadjustment may be limited either by the manufacturer or by a clinicianto a maximum adjustment to avoid instantaneous changes that cause abruptdiscomfort for patient 14.

Alternatively, the adaptation logic may simply indicate that an increaseis necessary, in which case a series of incremental increases areapplied at periodic intervals until the adaptation logic no longerindicates the need for an increase. For example, frequency may beincreased in 5 Hz increments for so long as the adaptation logicindicates the need for an increase. In this case, a hysteresis functionmay be built into the logic to avoid repeated up/down toggling of thestimulation parameters. The adjustments may be carried out at differentintervals, such as seconds, minutes, hours, and even days, subject tothe discretion of a clinician. In addition to increases or decreases inparameters, the adaptation logic also may indicate that the efficacy iswithin an acceptable range, and provide an output indicating no need foradjustment.

In one embodiment, the processor may also determine and modify, ifnecessary the frequency of analyzing and adjusting the stimulationparameters. For example, upon implantation, and soon thereafter, moreadjustment may be necessary or desirable to obtain the most beneficialstimulation settings. In one embodiment, the timing of when to analyzethe stimulation parameters can be determined at least in part byanalyzing the history of the stimulation parameters, and adjustmentthereof. Alternatively, the timing of the adjustment analysis can bepre-determined by a clinician, the manufacturer, the patient, or somecombination thereof. In yet another embodiment, the patient canindicate, based on a subjective analysis of the efficacy of the currentparameters, that the processor should analyze the stimulation parametersto determine if an adjustment is necessary.

In embodiments in which external monitor/programmer 22 or remotemonitoring/programming system 26 are permitted to directly andautomatically adjust the stimulation parameters of neurostimulator 12,the information may be analyzed on a periodic basis, e.g., at intervalson the order of seconds, minutes, hours or days. In some embodiments,external monitor/programmer 22 and remote monitoring/programming system26 may apply different analysis modes. In a first mode, the informationmay be analyzed and adjustments made at relatively infrequent periodicintervals on the order of several hours or several days.

In a second mode, external monitor/programmer 22 or remotemonitoring/programming system 26 may operate in a more intensiveanalysis and adjustment mode in which information is evaluated andparameters are adjusted very frequently until a desired level ofefficacy is achieved. This second, more intensive mode may continueuntil the efficacy level is driven into an acceptable range. Theintensive mode may be entered when analysis in the first, infrequentmode reveals efficacy levels that require stimulation parameteradjustments. Again, the adjustments made to the stimulation parametersin either mode may be performed automatically or subject to approval bya clinician, patient, or both.

In one embodiment, the processor can, without further input, orauthorization from any other source, input and utilize the newstimulation parameters. As discussed above, another embodiment requiresapproval by a clinician, through a remote monitoring/programming system26 before the new simulation parameters can be instituted and utilizedby the neurostimulator 12. In yet another embodiment, the processor cansend the new stimulation parameters to the external monitor/programmer22 for review and/or approval by the patient 14. In an alternativeembodiment, the external monitor/programmer 22 can display the proposednew stimulation parameters, seek patient approval to institute the newstimulation parameters, and maintain the previous stimulation parametersin memory. This embodiment could allow the patient to subjectivelycompare the efficacy of the two stimulation parameters and pick whichsettings they prefer. Furthermore, a number of previous stimulationparameters could be stored in memory to allow the patient to pick fromthem, or designate some as particularly efficacious, particularlyundesirable, or particularly efficacious for one or more activity levelsor types (i.e. a particularly desirable setting for exercise).

Sensor 20 may be chronically implanted within patient 14 for use over anextended period of time. In this case, sensor 20 carries sufficientbattery resources, a rechargeable battery, or an inductive powerinterface that permits extended operation. Sensor 20 may be implanted byminimally invasive, endoscopic techniques for an extended period of timeor a limited period of time to capture information useful in analyzingand adjusting the stimulation parameters. In other words, sensor 20 maybe chronically implanted to support ongoing parameter adjustments overan extended course of therapy spanning several months or years, orpurposefully implanted for a short period of time to support a one-timeparameter adjustment or a small number of adjustments over a relativelyshort period of time, such as several hours, days or weeks.

In some embodiments, sensor 20 transmits sensed information continuouslyor periodically to neurostimulator 12 or external monitor/programmer 22.In this case, sensor 20 monitors physiological conditions continuouslyor periodically. Alternatively, neurostimulator 12 or externalmonitor/programmer 22 may trigger activation of sensor 20 to captureinformation at desired intervals. In some cases, triggered activationmay occur when patient 14 enters information into externalmonitor/programmer 22 to indicate a voiding event. Triggered activationof sensor 20 may be useful in conserving battery life, if applicable, ofthe sensor 20 or neurostimulator 12. In each case, multiple sensors 20may be provided and dedicated to different parameters or differentlocations within the urinary tract.

Rather than immediately transmitting the urodynamic information toneurostimulator 12 or external monitor/programmer 22, sensor 20 mayinitially store the information internally for subsequent wirelesstransmission. Hence, in some embodiments, the information may be storedwithin sensor 20, and later transmitted to neurostimulator 12 orexternal monitor/programmer 22. In this case, neurostimulator 12 orexternal monitor/programmer 22 may interrogate sensor 20 to obtain thestored information for analysis and possible adjustment of stimulationparameters.

FIG. 2 is a functional block diagram illustrating implantable sensor 20of FIG. 1. In the example of FIG. 2, sensor 20 includes a sensorprocessor 30, a sensing element 32, memory 34, wireless telemetryinterface 36, and a power source 38. Sensor 20 also may include aninternal clock to track date and time of voiding events. Sensor 20 mayhave a capsule-like shape, and may be placed within bladder 14 orurethra 18 by endoscopic introduction via the urethra, or by hypodermicinjection using a hypodermic needle. Alternatively, sensor 20 may besurgically implanted. In the case of minimally invasive endoscopicintroduction, sensor 20 may be constructed in a manner similar to thesensors described in U.S. patent application Ser. No. 10/978,233, toMartin Gerber, filed Oct. 29, 2004, and entitled “Wireless UrinaryVoiding Diary System,” which claims the benefit of U.S. provisionalapplication No. 60/589,442, filed Jul. 20, 2004; or U.S. patentapplication Ser. No. 10/833,776, to Mark Christopherson and WarrenStarkebaum, filed Apr. 28, 2004, entitled “Implantable Urinary TractMonitor,” the entire content of each of which is incorporated herein byreference.

Power source 38 may take the form of a small battery. An external sourceof inductively coupled power may be used, in some embodiments, to powersome features of monitor 20, or to recharge the battery. For example,sensor 20 may include an inductive power interface for transcutaneousinductive power transfer to power higher energy functions such astelemetry. However, sensor 20 typically will include a small batterycell within the sensor housing. Alternatively, sensor 20 may include aninductive power interface in lieu of a battery.

Telemetry interface 36 permits wireless communication with externalmonitor/programmer 22, remote monitoring/programming system 26, orneurostimulator 12 for wireless transmission of information obtained bysensor 20, as well as wireless reception of activation triggers thatdirect sensor 20 to collect physiological information or transmit storedinformation. As a further alternative, triggered activation may beapplied by patient 14 in the form of a magnet swiped in proximity tosensor 20, in which case the monitor will include appropriate sensingcircuitry to detect the magnet.

Sensor processor 30 controls telemetry interface 36 and handlesprocessing and storage of information obtained by sensing element 32.Sensor processor 30 controls operation of sensor 20 and may include oneor more microprocessors, digital signal processors (DSPs),application-specific integrated circuits (ASICs), field-programmablegate arrays (FPGAs), or other equivalent logic circuitry. Memory 34 mayinclude any magnetic, electronic, or optical media, such as randomaccess memory (RAM), read-only memory (ROM), electronically-erasableprogrammable ROM (EEPROM), flash memory, or the like, or a combinationthereof. Memory 34 may store program instructions that, when executed bysensor processor 30, cause the controller to perform the functionsascribed to it herein. For example, memory 34 may store instructions forsensor processor 30 to execute in support of control of wirelesstelemetry interface 36 and control of, and processing of informationobtained by, sensing element 32. Memory 34 may include separate memoriesfor storage of instructions and urodynamic information.

Telemetry interface 36 may include a wireless radio frequency (RF)transmitter and receiver to permit bi-directional communication betweensensor 20, neurostimulator 12, external monitor/programmer 22, remotemonitoring/programming system 26, or some combination thereof. In thismanner, external monitor/programmer 22 may transmit commands to sensor20 for collection of information or collection of information stored inmemory 34, and receive status and operational information from thesensor 20. Telemetry interface 36 includes an antenna, which may take avariety of forms. For example, the antenna may be formed by a conductivecoil or wire embedded in a housing associated with sensor 20.Alternatively, the antenna may be mounted on a circuit board carryingother components of sensor 20, or take the form of a circuit trace onthe circuit board.

Battery power source 38 may take the form of a battery and powergeneration circuitry. In some embodiments, sensor 20 may be used for afew days or weeks, and therefore may not require substantial batteryresources. Accordingly, the battery within battery power source 38 maybe very small in some cases. An example of a suitable battery is theEnergizer 337 silver oxide cell, available from the Eveready BatteryCompany, of St. Louis, Mo., USA. The Energizer 337 battery isdisc-shaped, and has a diameter of 4.88 mm and thickness of 1.65 mm.Another example battery is the QL003I 3 milliamp cylindrical batteryfrom Quallion, LLC, of Sylmar, Calif., USA, which has a diameter ofapproximately 2.9 mm and a length of approximately 13.0 mm.

In further embodiments, battery power source 38 may be rechargeable viaelectromagnetic induction or ultrasonic energy transmission, andincludes an appropriate circuit for recovering transcutaneously receivedenergy. For example, battery power source 38 may include a secondarycoil and a rectifier circuit for inductive energy transfer. In stillother embodiments, battery power source 38 may not include any storageelement, and sensor 20 may be fully powered via transcutaneous inductiveenergy transfer, which may be provided by external receiver 14. Ineither case, sensor 20 may be constructed for short-term or long-termoperation.

Sensing element 32 may be selected for any of a variety of urodynamictesting applications, and may include appropriate signal processingcircuitry such as amplifier, filter, driver, and analog-to-digitalconversion circuitry for presentation of sensed information to sensorprocessor 30. For urodynamic testing, sensing element 32 may take theform of a pressure, flow, velocity, volume, temperature, impedance, orcontractile force sensor. For pressure measurements, for example,sensing element 32 may include one or more diaphragm sensors, straingauge sensors, capacitive sensors, piezoelectric sensors, or othersensors used in conventional catheter-based urodynamic testing to sensepressure. As a further example, for bladder emptying, sensing element 32may include a conductive sensor to sense the presence of urine withinthe lower region of the bladder 16.

For flow measurements, sensing element 32 may comprise a pulsed Dopplerultrasonic sensor, or a laser Doppler flow sensor. Doppler shifting ofthe frequency of the reflected energy indicates the velocity of thefluid flow passing over a surface of sensing element 32. Consequently,in some embodiments, sensor 20 may include circuitry, such as aquadrature phase detector, in order to enable the monitor to distinguishthe direction of the flow of fluid in addition to its velocity.

As a further example, sensing element 32 may include any one or morethermal-convection velocity sensors. A thermal-convection velocitysensor may include a heating element upstream of a thermistor to heaturine within the urethra 18 such that flow rate may be measuredaccording to the temperature of the heated fluid when it arrives at thethermistor. In other embodiments, flow rate may be determined from theoutput of a concentration or temperature sensor using Fick's techniques.

In some embodiments, sensing element 32 may include multiple sensors ofa given type, as well as multiple types of sensors, e.g., pressure,flow, bladder emptying, or the like. Accordingly, the informationobtained by sensor 20 may then include different types of physiologicalparameters associated with a voiding event. Alternatively, multiplesensors 20 may be deployed within bladder 16 or urethra 18. In thiscase, each sensor 20 may be configured with a different type or set ofsensing elements 32 to collect a variety of different urodynamicparameters during a voiding event.

In some other embodiments, sensing element 32 may be chosen to sense aphysiological state, such as an activity type, activity level, orposture of the patient 14. For example, sensing element 32 can includean accelerometer to detect an elevated activity level, or a decreasedactivity level.

FIG. 3 is a functional block diagram illustrating externalmonitor/programmer 22. In the example of FIG. 3, externalmonitor/programmer 22 includes a processor 40, memory 42, power source44, telemetry interface 46, user input device 48 and display 50. Userinput device 48 may take the form of a set of buttons, a keypad, atouchscreen, soft keys on a display, or other input media. Display 50may be a liquid crystal display (LCD), plasma display, or the like,which conveys status and operational information to the patient 14, andaids the patient in entry of information into externalmonitor/programmer 22.

Memory 42 stores instructions for execution by processor 40, as well asa set of adaptation logic 43, which may be expressed, e.g., in terms ofone or more functions or lookup table entries. In addition, memory 42may store information received from sensor 20, neurostimulator 12, andpatient 14. Memory 36 may include separate memories for storage ofinstructions and information received from sensor 20, neurostimulator 12or patient 14. Processor 40 may be constructed in a variety of ways, asdescribed above with respect to sensor processor 30 of FIG. 2, includingas one or more microprocessors, an ASIC, an FPGA, or a combinationthereof. It should also be understood and appreciated by one of skill inthe art that the functions of the processor 40 as described above withrespect to the adaptation logic could be undertaken by a similarprocessor associated with the neurostimulator 12, the sensor 20, theremote monitoring/programming system 26, or some combination thereof.For example, in one embodiment, the information gathered from sensor 20could be weighted accordingly via adaptation logic stored in memory andcarried out by a processor within sensor 20 and then transmitted viawireless telemetry to a processor in external monitor/programmer 22 toincorporate those weighted factors in to the analysis of the stimulationsettings.

Processor 40 controls telemetry interface 46 to obtain urodynamicinformation from sensor 20, neurostimulator 12, or some combinationthereof. Processor 40 also may control telemetry interface 46 to receiveinformation from sensor 20 or neurostimulator 12 on a substantiallycontinuous basis, at periodic intervals, or only upon receipt of anactivation command. Hence, external monitor/programmer 22 may obtain anongoing indication of the physiological conditions sensed by sensor 20,or receive periodic updates upon triggered activation of sensor 20. Forexample, external monitor/programmer 22 may be configured to respond toa voiding event activation command entered by patient 14 via user inputdevice 48. In response to the voiding event activation command, externalmonitor/programmer 22 generates an activation control signal andtransmits the control signal to sensor 20 via telemetry interface 46.

Wireless telemetry may be accomplished by radio frequency (RF)communication or proximal inductive interaction of externalmonitor/programmer 22 with sensor 20 or neurostimulator 12.Alternatively, telemetry interfaces 36, 46 may be configured for sensor20 and external monitor/programmer 22 to support radio frequency (RF)communication with a sufficiently strong signal such that proximateinteraction is not required. In addition to an RF or inductive telemetryinterface 46, external monitor/programmer 22 may include a wired orwireless interface 51 for communication with other external devices,e.g., either directly or via network 24.

External monitor/programmer 22 may take the form of a portable, handhelddevice, like a pager, cell phone, or patient programmer that can becarried by patient 14. External monitor/programmer 22 may include aninternal antenna, an external antenna protruding from the devicehousing, or an external antenna that extends from the device housing ona cable and is attached to the body of patient 14 at a locationproximate to the location of neurostimulator 12 or sensor 20 to improvewireless communication reliability. Also, in some embodiments, externalmonitor/programmer 22 also may receive operational or status informationfrom neurostimulator 12 or sensor 20, and may be configured to activelyconfigure and interrogate the neurostimulator 12 or sensor 20 to receivethe information.

With adaptation logic 43, processor 40 of external monitor/programmer 22may be programmed to analyze information obtained from neurostimulator12, sensor 20, or patient 14, and generate proposed adjustments to thestimulation parameters based on the information. Hence, in someembodiments, at least some portion of the intelligence for formulatingparameter adjustments may reside within external monitor/programmer 22.In other embodiments, however, at least a portion of the intelligencemay reside within remote monitoring/programming system 26. In otherembodiments, at least a portion of the intelligence for formulatingstimulation parameter adjustments may reside within neurostimulator 12.In further embodiments, at least a portion of the intelligence forformulating parameter adjustments may reside within the sensor(s) 20.Alternatively, external monitor/programmer 22, remotemonitoring/programming system 26, neurostimulator 12, and sensor(s) 20may provide shared intelligence for analysis of received information andgeneration of proposed stimulation parameter adjustments.

In some embodiments, external monitor/programmer 22 may generate avoiding diary, substantially as described in the aforementioned U.S.patent application Ser. No. 10/978,233, to Martin Gerber, filed Oct. 29,2004, and entitled “Wireless Urinary Voiding Diary System.” In thiscase, external monitor/programmer 22 tracks voiding events and otherinformation. As a further variation, in some embodiments, the adaptationlogic may be provided within neurostimulator 12. In particular, externalmonitor/programmer 22 may download to neurostimulator 12, periodicallyor on demand, information obtained from neurostimulator 12, sensor 20,or the patient through the external monitor/programmer 22, includingvoiding diary information in some instances. Neurostimulator 12 then maybe configured to analyze the information and make stimulation parameteradjustments based on the information, much like externalmonitor/programmer 22 or remote monitoring/programming system 26. Hence,in this case, analysis and adjustments are made within neurostimulator12 based on information recorded in external monitor/programmer 22. Instill other embodiments, neurostimulator 12 may be configured toimplement both recording of information and analysis and stimulationparameter adjustments.

FIG. 4 is a block diagram illustrating neurostimulator 12. As shown inFIG. 4, neurostimulator 12 includes a processor 52, memory 54, powersource 56, telemetry interface 58, and therapy delivery circuit 60.Memory 54 stores one or more neurostimulation programs that specifyneurostimulation parameters for stimulation pulses delivered by therapydelivery circuit 60. The parameters may be adjusted automatically orupon clinician approval by external monitor/programmer 22, whichdownloads or inputs new programs, new parameters or stimulationparameter adjustments to neurostimulator 12.

In general, the stimulation parameters are selected to have valueseffective in controlling or managing symptoms of urinary incontinence,such as involuntary leakage. An exemplary range of neurostimulationstimulation pulse parameters likely to be effective in treatingincontinence, e.g., when applied to the sacral or pudendal nerves, areas follows:

1. Frequency: between approximately 0.5 Hz and 500 Hz, in anotherembodiment between approximately 10 Hz and 250 Hz, and in yet anotherembodiment between approximately 10 Hz and 25 Hz.

2. Amplitude: between approximately 0.1 volts and 50 volts, in anotherembodiment between approximately 0.5 volts and 20 volts, and in yetanother embodiment between approximately 1 volt and 10 volts.

3. Pulse Width: between about 10 microseconds and 5000 microseconds, inanother embodiment between approximately 100 microseconds and 1000microseconds, and in yet another embodiment between approximately 180microseconds and 450 microseconds.

Therapy delivery circuit 60 drives one or more leads. In the example ofFIG. 4, therapy delivery circuit 60 drives electrodes carried by a pairof leads 62, 64. Leads 62, 64 extend from the housing of neurostimulator12, and have a distal end that extends to target nerve sites within thepelvic floor, such as sacral or pudendal nerve sites. Each lead 62, 64may carry one of more electrodes, and may be configured as an axial leadwith ring electrodes or a paddle lead with electrode pads arranged in atwo-dimensional array. The electrodes may operate in a bipolar ormulti-polar configuration with other electrodes, or may operate in aunipolar configuration referenced to an electrode carried by the devicehousing or “can” of neurostimulator 12.

Power source 56 may be a battery, either rechargeable ornon-rechargeable. In the case of a rechargeable battery, power source 56may include an inductive power interface for recharging. In otherembodiments, power source 56 may be powered entirely by inductive powertransfer from an external power source. Telemetry interface 58 may beconstructed and function in a manner similar to telemetry interface 36of implantable sensor 20 of FIG. 2. Processor 52 may be constructed in avariety of ways, as described above with respect to sensor processor 30of FIG. 2, including as one or more microprocessors, an ASIC, an FPGA,or a combination thereof.

FIG. 5 is a block diagram illustrating a remote monitoring/programmingsystem 26. As shown in FIG. 5, remote monitoring/programming system 26may include a monitoring server 66, a web server 68, an email server 69,a programming server 70, a network link 72, a patient database 74, orsome combination thereof. Monitoring server 66 listens for networktraffic over network link 72 from one or more externalmonitor/programmers 22 associated with various patients, receivesinformation from the external monitor/programmers 22, and records theinformation in a record in patient database 74. Patient database 74 maystore information for multiple patients in an organized form thatpermits ready retrieval of information for analysis, reporting, andhistorical archival.

Web server 68 generates web pages that contain information obtained forone or more patients, including information obtained from externalmonitor/programmers 22. The information may be presented in a variety offormats and levels of detail. Using clinician terminal 28, equipped witha web browser, a clinician can view information contained in patientdatabase 74 by accessing web server 68. Web server 68 also may beconfigured to execute database access commands to retrieve desiredinformation. In some embodiments, the information may be organized usinga hierarchy of XML tags.

The information contained in the web pages also may include proposedstimulation parameter adjustments. The stimulation parameter adjustmentsmay be generated by an external monitor/programmer 22 or remotemonitoring/programming system 26. A clinician may approve thestimulation parameter adjustments by clicking on a button within the webpage. Upon receipt of clinician approval, remote monitoring/programmingsystem 26 may then proceed to interact with an appropriate externalmonitor/programmer 22 to implement the stimulation parameter changes inthe pertinent neurostimulator 12. The web page generated by web server68 also may offer the clinician the opportunity to modify the proposedstimulation parameter adjustments before approval, e.g., using boxes,drop down menus, slider bars, radio buttons, or the like. In this case,remote monitoring/programming system 26 implements the stimulationparameter adjustments as modified by the clinician.

Email server 69 provides email notifications to a clinician terminal 28,if desired. The email notifications may report newly acquiredinformation for a particular patient 14, or proposed stimulationparameter adjustments for the patient. The email notifications mayinclude links to web pages for approval or modification of the proposedstimulation parameter adjustments. Alternatively, in some embodiments,the clinician may approve stimulation parameter adjustments by replyingto the email notification. In either case, the proposed stimulationparameter adjustments are not implemented until approval is received. Inother embodiments, however, it is conceivable that stimulation parameteradjustments may be fully automatic, and not require clinician approval,particularly if stimulation parameter adjustments are subject topre-programmed limits within the external monitor/programmer or theneurostimulator 12.

Programming server 70 analyzes information obtained from neurostimulator12, sensor 20, patient 14, or some combination thereof, via externalmonitor/programmer 22. In particular, like processor 40 of FIG. 3,programming server 70 may apply adaptation logic 43 to determine whetherstimulation parameters applied by neurostimulator 12 should be adjusted.If so, programming server 70 generates a set of stimulation parameteradjustments and transmits the adjustments to external monitor/programmer22, either automatically or upon clinician approval, for download orinput to neurostimulator 12.

When a new set of stimulation parameter adjustments is formulated,programming server 70 stores the adjustments in patient database 74. Thenext time web server 68 accesses database 74 to assemble a web page forviewing by a clinician, the web page will include the stimulationparameter adjustments. For email notifications, programming server 70 ordatabase 74 may generate a command that directs email server 69 toprepare a notification of the new stimulation parameter adjustments foremail delivery to clinician terminal 28. Upon approval of theadjustments by the clinician, programming server 70 releases theadjustments to external monitor/programmer 22 for downloading or inputto neurostimulator 12. Although programming server 70 formulates theadjustments in the example of FIG. 5, in other embodiments, theprogramming server may be responsible for presenting adjustmentsformulated by external monitor/programmer 22 for approval.

FIG. 6 is a block diagram illustrating a system for remote monitoringand programming of neurostimulators 12. FIG. 6 generally illustrates theinteraction of multiple neurostimulators 12A, 12B with respectiveexternal monitor/programmers 22A, 22B, remote monitor/programming system26, multiple clinician terminals 28A, 28B and, optionally, a patientterminal 75 via network 24. Clinician terminals 28A, 28B permit multipleclinicians to view information for multiple patients 14. The informationmay include information obtained from sensors 20, neurostimulators 12,and the patients 14 themselves, as well as proposed stimulationparameter adjustments. In some embodiments, multiple clinicians mayconsult with one another via clinician terminals 28A, 28B. Patientterminal 75 may permit a patient to view a limited set of information,e.g., by viewing patient web pages prepared by remotemonitoring/programming system 26.

In some embodiments, the system of FIG. 6, or a similarly constructedsystem, may be used to support clinical research. For example, externalmonitor/programmer 22, remote monitoring/programming system 26 andclinician terminals 28A, 28B may permit clinical researchers to accessinformation obtained from implanted neurostimulators 12 for purposes ofresearch, and not necessarily for adjustment of stimulation parameters.Rather, researchers may access the information obtained from externalmonitor/programmer 22 and remote monitoring/programming system 26 viaclinician terminals 28A, 28B to gather information in support of shortor long range research for formulation of improved or enhancedtherapies.

FIG. 7 is flow diagram illustrating operation of externalmonitor/programmer 22 to adjust stimulation parameters based oninformation obtained from a neurostimulator 12, an implantable sensor20, and a patient 14. As shown in FIG. 7, a processor associated withexternal monitor/programmer 22 for example may receive therapyinformation (76) from implanted neurostimulator 12, indicatingstimulation parameters associated with neurostimulation therapydelivered by the neurostimulator, as well as the timing of the delivery.Alternatively, such information may already be available within externalmonitor/programmer 22 by virtue of the fact that externalmonitor/programmer 22 is responsible for programming neurostimulator 12.However, therapy information may additionally include operationalinformation associated with neurostimulator 12.

In addition, the processor within the external monitor/programmer 22 inthis example receives patient information from the patient (78). Thepatient information may include any of the information exemplified anddescribed above. External monitor/programmer 22 also may receive sensorinformation (80) in embodiments in which system 10 includes one or moreimplantable sensors 20. Again, the sensor information may representphysiological conditions within the urinary tract, as exemplified above.Together, the therapy information, patient information, and sensorinformation may provide an effective representation of the level ofefficacy provided by the existing stimulation parameters.

Upon analysis of the received information (82), using a set ofadaptation logic, external monitor/programmer 22 may adjust thestimulation parameters (84) presently applied by neurostimulator 12.Alternatively, external monitor/programmer 22 may determine that thereis no need to adjust the stimulation parameters. If the stimulationparameters are adjusted, external monitor/programmer 22 programs theneurostimulator 12 by wireless telemetry to apply the modifiedstimulation parameters. Programming may be entirely automatic or subjectto clinician approval. In either case, the adjusted stimulationparameters are selected to enhance the efficacy of the neurostimulationtherapy delivered by neurostimulator 12 in alleviating incontinence.

FIG. 8 is a flow diagram illustrating operation of a remotemonitoring/programming system 26 to adjust neurostimulation parametersbased on information obtained from a neurostimulator 12, an implantablesensor 20, and a patient 14. As shown in FIG. 8, the processor withinthe remote monitoring/programming system 26, in this example, receivesinformation from external monitor/programmer 22 (88) and matches theinformation with a patient record in database 74 (90). Remotemonitoring/programming system 26 analyzes the information (92), applyinga set of adaptation logic, and generates proposed stimulation parameteradjustments based on the analysis (94).

Remote monitoring/programming system 26 presents the proposedadjustments to a clinician for approval (96). If the adjustments areapproved (98), remote monitoring/programming system 26 transmits theadjustments to external monitor/programmer 22 (100), which downloads orinputs the stimulation parameter adjustments into neurostimulator 12. Ifapproval is not obtained, the stimulation parameter adjustments are notloaded into neurostimulator 12, and the process stops. In someembodiments, however, the adjustments may be loaded automaticallywithout approval.

The adaptation logic 43 applied by external monitor/programmer 22 orprogramming server 76 may be subject to wide variation. In general, theadaptation logic 43 may perform a weighted summation of a selected setof values derived from the information obtained from neurostimulator 12,sensor 20, patient 14, or some combination thereof. In some embodiments,the sum may represent a cost of the present stimulation parameters, interms of a level of efficacy. If the information indicates thatneurostimulator 12 is operating within a desirable range of efficacy,for example, there may be zero cost. If the efficacy level deviates fromthe desired range, however, the cost increases. The cost may becorrelated to adjustments of one or more stimulation parameters to drivethe cost back to zero.

As a very simple example, if the information obtained by externalmonitor/programmer 22 indicates that the patient has experienced Nleakage events, the cost function will yield a non-zero cost, as anyleakage is generally unacceptable. In this case, the cost function maydrive an increase in stimulation frequency to more vigorously stimulatethe bladder to avoid involuntary leakage. The increase may beimplemented in an instantaneous step change, or in a series ofincremental steps.

On the other hand, if there are no leakage events, but physiologicalinformation obtained from sensor 20 indicates that sphincter closingpressure is unsatisfactory, or that the bladder is exhibiting anundesirable contractile force, the cost function may yield a non-zerocost, albeit a cost that is much less than the cost resulting fromundesirable leakage events. In this case, a less aggressive adjustmentin stimulation frequency may be applied as a preemptive measure againstpossible leakage events.

As another example, activity information entered by patient 14 mayindicate that leakage events are more prevalent when the patient isexerting himself at work or during exercise. In this case, based on thenumber of leakage events and the contractile force of sphincter pressurerecorded at the time of such leakage events, stimulation parameters areadjusted to provide more vigorous stimulation during exercise. To thatend, the patient may be permitted to select different stimulationprograms containing parameters targeted to specific activities ofpostures.

Although the structure and organization of the adaptation logic 43 maybe subject to wide variation, in general, the invention permits deliveryof an adaptive neurostimulation therapy that dynamically adjusts todifferent conditions, and maintains or enhances neurostimulationefficacy for patient 14. An adaptive neurostimulation therapy can beexpected to provide more beneficial results for patient 14 relative tostatic neurostimulation therapies that rely only on fixed clinicalprogramming of stimulation parameters.

In some embodiments, adaptation logic 43 may be configured to applyparticular algorithms such as genetic algorithms, Bayesianclassification, neural networks, or decision trees. In those cases,adaptation logic 43 may be formulated to implement algorithms similar tothose described in U.S. patent application Ser. No. 10/767,674, toSteven M. Goetz, filed Jan. 29, 2004, and entitled “SELECTION OFNEUROSTIMULATOR PARAMETER CONFIGURATIONS USING BAYESIAN NETWORKS,” U.S.patent application Ser. No. 10/767,922, to Steven M. Goetz, filed Jan.29, 2004 and entitled “SELECTION OF NEUROSTIMULATOR PARAMETERCONFIGURATIONS USING NEURAL NETWORKS,” U.S. patent application Ser. No.10/767,545, to Steven M. Goetz, filed Jan. 29, 2004 and entitled“SELECTION OF NEUROSTIMULATOR PARAMETER CONFIGURATIONS USING DECISIONTREES,” and U.S. patent application Ser. No. 10/767,692, to Steven M.Goetz, filed Jan. 29, 2004 and entitled “SELECTION OF NEUROSTIMULATORPARAMETER CONFIGURATIONS USING GENETIC ALGORITHMS,” the entire contentof each of which is incorporated herein by reference.

One embodiment of the invention includes a neurostimulation therapy forincontinence having the steps of receiving, in an external programmer,information relating to the efficacy of neurostimulation therapydelivered by an implanted neurostimulator to manage urinaryincontinence; adjusting, in a processor, one or more stimulationsettings of the neurostimulation therapy based on the receivedinformation and adaptive logic; and inputting the adjusted parametersfrom the processor to the implanted neurostimulator. A system forperforming the above method that includes an external programmer, aprocessor, and an implantable neurostimulator is also included.Computer-readable medium that includes instructions for carrying out theabove method is also included.

Another embodiment of the invention includes a neurostimulation therapyfor incontinence having the steps of receiving, in an externalprogrammer, information relating to the efficacy of neurostimulationtherapy delivered by an implanted neurostimulator to manage urinaryincontinence; sensing, via at least one sensor, information related tothe efficacy of neurostimulation therapy delivered by an implantedneurostimulator; adjusting, in a processor, one or more stimulationsettings of the neurostimulation therapy based on the receivedinformation and adaptive logic; and inputting the adjusted parametersfrom the processor to the implanted neurostimulator. A system forperforming the above method that includes an external programmer, aprocessor, and an implantable neurostimulator is also included.Computer-readable medium that includes instructions for carrying out theabove method is also included.

Another embodiment of the invention includes a neurostimulation therapyfor incontinence having the steps of receiving, in a processor,information relating to an implanted neurostimulator to manage urinaryincontinence; sensing, via at least one sensor, information related tothe efficacy of neurostimulation therapy delivered by an implantedneurostimulator; adjusting, in a processor, one or more stimulationsettings of the neurostimulation therapy based on the sensedinformation, received information and adaptive logic; and inputting theadjusted parameters from the processor to the implanted neurostimulator.A system for performing the above method that includes an externalprogrammer, a processor, and an implantable neurostimulator is alsoincluded. Computer-readable medium that includes instructions forcarrying out the above method is also included.

Many embodiments of the invention have been described. Variousembodiments may be adapted to provide adaptive neurostimulation forother pelvic floor disorder such as fecal incontinence, sexualdysfunction, cystitis, or the like. Accordingly, while the invention hasbeen described in the context of urinary incontinence for purposes ofillustration, it is not so limited.

Many embodiments of the invention have been described. These and otherembodiments are within the scope of the following claims.

1. A method comprising: receiving in a processor an operationinformation from an implantable neurostimulator for delivery of aneurostimulation therapy to manage urinary incontinence, the delivery ofthe neurostimulation therapy being based on a plurality of stimulationparameters; sensing, via at least one sensor, sensed information relatedto the efficacy of the neurostimulation therapy delivered by animplantable neurostimulator; wirelessly transmitting the sensedinformation from the sensor to the processor; selecting, usingadaptation logic, at lease one parameter from the plurality ofstimulation parameters based on the sensed information and the operationinformation from the implantable neurostimulator; determining, in theprocessor, an adjustment of the at least one parameter; proposing amodified at least one parameter to a user based, at least in part, onthe adjustment of the at least one parameter; the user choosing adisposition for the modified at least one parameter; inputting themodified at least one parameter from the processor to the implantedneurostimulator based on the disposition.
 2. The method of claim 1,wherein the operation information from the implantable neurostimulatoris information regarding the stimulation parameters of theneurostimulator, the elapsed time since the neurostimulator wasimplanted, the elapsed time since the settings were adjusted, thebattery status, the charging status, the lead impedance, the telemetrystatus, or some combination thereof.
 3. The method of claim 2, whereinthe information regarding the settings of the implantableneurostimulator is frequency, amplitude, cycling parameters,identification of electrodes that are being utilized, or somecombination thereof.
 4. The method of claim 1, wherein the sensedinformation is information regarding the functioning of the bladder, orany other segment of the patient's urinary tract.
 5. The method of claim4, wherein the sensed information relates to bladder pressure, bladdercontractile force, urinary sphincter pressure, urine flow rate, urineflow pressure, voiding amount, or some combination thereof.
 6. Themethod of claim 4, wherein the sensed information relates to urine flowvelocity, urine or bladder temperature, impedance, urinary pH, orchemical constituency of the urine, or some combination thereof.
 7. Themethod of claim 4, wherein the sensed information relates to aphysiological state of the patient.
 8. The method of claim 7, whereinthe sensed information is cardiac activity, respiratory activity,electromyographic activity, or some combination thereof.
 9. The methodof claim 7, wherein the sensed information detects a posture or activitylevel of the patient.
 10. The method of claim 1, wherein the processoris associated with the at least one sensor.
 11. The method of claim 1,wherein the processor is associated with the implanted neurostimulator.12. The method of claim 1, wherein the sensed information, the operationinformation from the implantable neurostimulator, or some combinationthereof is sent via wireless telemetry.
 13. The method of claim 1,wherein the processor is in communication with a remote programmer. 14.The method as in claim 1, wherein the processor is an externalprocessor.
 15. A system for delivering therapy to a patient, comprising:an implantable neurological stimulator, comprising: a therapy deliverycircuit delivering therapy based on a plurality of stimulationparameters; a memory module storing said plurality of stimulationparameters and an operating information; and an implantable neurologicalstimulator wireless telemetry interface operatively coupled to saidmemory module; an implantable sensor, comprising: a sensing elementobtaining sensed information related to efficacy of said therapy; and asensor wireless telemetry interface operatively coupled to said sensingelement; and a processor receiving said sensed information by way ofsaid sensor wireless telemetry interface and said operating informationby way of said implantable neurological stimulator wireless telemetryinterface; and a user interface operatively coupled with said processor;wherein said processor is configured to select, using adaptation logic,at least one parameter from said plurality of parameters based on saidsensed information and said operating information; wherein the processoris further configured to determine an adjustment of said at least oneparameter; wherein said user interface displays a modified at least oneparameter to a user based, at least in part, on said adjustment of saidat least one parameter; wherein said user interface is configured toallow said user to select a disposition for said modified at least oneparameter; and wherein said modified at least one parameter is stored insaid memory module based on said disposition.
 16. The system as in claim15: further comprising an external programmer having an externalwireless telemetry interface in wireless communication with said sensorwireless telemetry interface and said implantable stimulator wirelesstelemetry interface; and wherein said processor is a component of saidexternal programmer.
 17. The system as in claim 15: wherein saidprocessor is a component of said implantable neurological stimulator,said processor operatively coupled with said implantable neurologicalstimulator wireless telemetry interface; and said implantableneurological stimulator wireless telemetry interface operatively coupledwith said sensor wireless telemetry interface.
 18. The system as inclaim 16, wherein said external programmer comprises an externalprogrammer network link operatively coupled to said external wirelesstelemetry interface and connecting said external programmer to theinternet.
 19. The system as in claim 18, further comprising a remotemonitor, comprising: a remote network link, operatively coupled via theinternet to said external programmer network link; a server, said serverreceiving and storing said sensed information by way of said remotenetwork link, adjusting said at least one stimulation parameter based onsaid sensed information, and storing said at least one stimulationparameter in said memory module.
 20. The system as in claim 19: furthercomprising a plurality of said remote stations; wherein each individualone of said plurality of said remote stations is operatively coupled toother individual ones of said plurality of remote stations via saidremote network link.
 21. The system as in claim 20 wherein individualones of said plurality of remote stations is operatively coupled to saidexternal programmer via said remote network link.
 22. The system as inclaim 15, wherein the processor is an external processor.